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Capa Manager Jobs in Saugus, MA (NOW HIRING)

Novocure

Manager, Technical Complaints

Boston, MA · On-site

$110K - $143K/yr

Manager, Technical Complaints At Novocure, we're working to extend the lives of patients battling ... Identify quality signals and partner on CAPA and continuous improvement initiatives. Support FDA ...

Novocure

Manager, Technical Complaints

Boston, MA · Hybrid

$110K - $143K/yr

Manager, Technical Complaints Hybrid / Full Time / Portsmouth, NH At Novocure, we're working to ... Identify quality signals and partner on CAPA and continuous improvement initiatives. * Support FDA ...

RXinsider LTD.

EHS&S Sr. Manager

Norwood, MA · On-site

$131 - $209/hr

The candidate will play a key role in managing EHS events, conducting investigations, implementing CAPA, owning individual EHS programs, and maintaining compliance with applicable EHS programs under ...

Novocure Inc

Manager, Technical Complaints

Boston, MA · On-site

$110K - $143K/yr

Manager, Technical Complaints Hybrid / Full Time / Portsmouth, NH At Novocure, we're working to ... Identify quality signals and partner on CAPA and continuous improvement initiatives. * Support FDA ...

Moderna Therapeutics

EHS&S Sr. Manager

Norwood, MA

$93K - $127K/yr

The candidate will play a key role in managing EHS events, conducting investigations, implementing CAPA, owning individual EHS programs, and maintaining compliance with applicable EHS programs under ...

Moderna, Inc.

EHS&S Sr. Manager

Norwood, MA · On-site

$93K - $127K/yr

The candidate will play a key role in managing EHS events, conducting investigations, implementing CAPA, owning individual EHS programs, and maintaining compliance with applicable EHS programs under ...

Moderna Therapeutics

EHS&S Sr. Manager

Norwood, MA · On-site

$130.80 - $209.40/hr

The candidate will play a key role in managing EHS events, conducting investigations, implementing CAPA, owning individual EHS programs, and maintaining compliance with applicable EHS programs under ...

Initial Therapeutics, Inc.

EHS&S Sr. Manager

Norwood, MA · On-site

$130.80 - $209.40/hr

The candidate will play a key role in managing EHS events, conducting investigations, implementing CAPA, owning individual EHS programs, and maintaining compliance with applicable EHS programs under ...

Cox Engineering

Quality Assurance Manager

Randolph, MA

$100K - $120K/yr

Job Title: QA/QC Manager Position Summary The QA/QC Manager leads the Quality function at the ... Nonconformance, CAPA amp; Continuous Improvement * Lead Nonconformance (NCR) and Corrective ...

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All JobsCapa JobsCapa Manager JobsCapa Manager Jobs in Saugus, MA

Capa Manager information

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What job categories do people searching Capa Manager jobs in Saugus, MA look for?

The top searched job categories for Capa Manager jobs in Saugus, MA are:

What cities near Saugus, MA are hiring for Capa Manager jobs?

Cities near Saugus, MA with the most Capa Manager job openings:

Capa Manager jobs near you

Regulatory Affairs & Compliance Manager, PET Production Facility

Massgeneralbrigham

Boston, MA • On-site

$99K - $141K/yr

Full-time

Re-posted 28 days ago

Job description

Site: The General Hospital Corporation


Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.



Job Summary

PRINCIPAL DUTIES AND RESPONSIBILITIES:
Duties and responsibilities include the following but is not limited to:
Authors and reviews of standard operating procedures, technical reports, and other cGMP documents
Educates staff and organizational members and project participants on quality improvement methodologies and tools
Provides leadership and hands-on participation in projects to develop quality improvement skills
Develops a quality improvement culture with staff and leaders to support organizational development
Maintains an updated library of FDA regulations and guidance documents
Performs annual product quality review for each radiopharmaceutical
OOS investigation coordination
Change control management
CAPA management and verification of efficacy
Vendor complaint handling
Assists with IND submissions, annual reports, amendments, etc.
Maintain inspectional readiness
Tracking and trending data related to investigations, environmental monitoring, production
Record keeping maintaining compliance with the following regulatory authorities:
oMassachusetts Department of Public Health
oMassachusetts Board of Pharmacy
oFood and Drug Administration
oRadiation Safety Department
oHospital Policies
Collaboration with PET Production/Cyclotron staff in the performance of quality investigations
Maintaining a positive working relationship with vendors and hospital service providers (e.g. Buildings and Grounds)
Documentation of facility repairs
Calibrated equipment inventory management
Equipment IQ/OQ documentation review
Documentation management per institution document control policy
Leads improvements to quality management system
Serves as liaison between industry partners and facility for collab oration work
Oversees personnel training program and documentation


Qualifications

  • The MGH PET Production Facility produces radiopharmaceuticals for clinical use, human research, and non-human research applications.
    The MGH PET Production facility is an FDA registered PET Radiopharmaceutical manufacturing facility. Applicant will work in a cGMP facility located in the Edwards Research Building Basement.
    This position is mainly office-based, in-person, although a portion of the duties will require working in the laboratory where radiopharmaceuticals are manufactured. While significant safety measures are in place, there is limited exposure to ionizing radiation and a low probability of exposure to volatile chemicals in the laboratory. Staff will wear dosimeters to measure radiation exposure.
    Work hours may be variable to ensure that departmental needs are met.

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS: Specify minimum credentials and clearly indicate if required or preferred.

Preferred: Certification in quality management or other cGMP certification.

EDUCATION:

Bachelor's degree required

* Field of Study/Additional Specialized Training including the following are preferred:

  • Regulatory Affairs

  • Pharmaceutical Science, manufacturing, or other related field

Required:

  • 3 - 5 years of direct experience in a pharmaceutical manufacturing field

  • 2-3 years supervisory experience

Preferred:

  • 5 - 10 years of direct experience in a pharmaceutical manufacturing field

  • Professional certification


Additional Job Details (if applicable)


Remote Type

Onsite


Work Location

60 Blossom Street


Pay Range

$99,465.60 - $141,804.00/Annual


Grade

8


At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.


EEO Statement:

1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.


Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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